The Effects of Instrument-Assisted Soft Tissue Mobilization and Vibration Therapy on Pain, Functionality, and Kinesiophobia in Individuals With Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The aim of this study is to investigate the effects of Instrument-Assisted Soft Tissue Mobilization and vibration massage therapy on pain, functionality, and kinesiophobia in individuals with lumbar disc herniation.
详细描述
The aim of this study is to investigate the effects of Instrument-Assisted Soft Tissue Mobilization and Percussion massage therapy on pain, functionality, and kinesiophobia in individuals with lumbar disc herniation. In addition, participants will be randomly assigned to three groups Conventional Therapy, Percussion Massage Therapy, and IASTM and the study will aim to examine and compare the pre- and post-treatment effects of these three interventions on pain, functionality, and kinesiophobia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between 30 and 60 years of age
- •Individuals diagnosed with lumbar disc herniation at the protrusion level
- •Individuals with no cognitive, intellectual, or mental impairments and who are able to express themselves
- •Individuals with a VAS score greater than 5
- •Individuals experiencing pain for at least 3 months
排除标准
- •Individuals with a history of lumbar surgery
- •Individuals who are pregnant
- •Individuals who have had a spinal tumor or any other malignancy within the past six months
- •Individuals who have received physiotherapy for low back pain within the last six months
- •Individuals with orthopedic conditions such as fractures
- •Individuals diagnosed with neurological, rheumatological, or psychological disorders
- •Individuals with diagnoses such as infection, spondylosis, spondylolysis, osteoporosis, or ankylosing spondylitis will be excluded from the study.
结局指标
主要结局
Visual Analog Scale
时间窗: From enrollment to the end of treatment at 4 weeks
the Visual Analog Scale (VAS) will be used to assess pain intensity. VAS is a widely used tool in daily clinical practice for evaluating pain, and the average pain score ranges from 0 to 10. The VAS is typically defined as a 10-cm horizontal or vertical line that begins with "no pain" and ends with "unbearable pain." This line may be presented as a simple straight line or divided into equal segments. Participants will be asked to mark a point on the line that corresponds to the intensity of their pain. A score of "0" indicates no pain, scores of 1-4 represent mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 reflect severe pain.
Tampa Scale of Kinesiophobia
时间窗: From enrollment to the end of treatment at 4 weeks
The Tampa Scale of Kinesiophobia (TSK) will be used to assess kinesiophobia. This scale is commonly applied in individuals with acute and chronic low back pain, fibromyalgia, and musculoskeletal injuries. The TSK is a 17-item questionnaire developed to measure fear of movement and fear of reinjury, particularly in relation to work-related activities and fear-avoidance behaviors. It uses a 4-point Likert scoring system (1 = Strongly disagree, 4 = Strongly agree). The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
The Oswestry Disability Index
时间窗: From enrollment to the end of treatment at 4 weeks
The Oswestry Disability Index (ODI) will be used to assess functional status. The ODI consists of 10 items scored on a scale from 0 to 5 and evaluates pain and limitations in various daily activities in individuals with low back pain. A score of 5 represents the highest level of disability for each item. The maximum possible score is 100%, indicating complete disability. The total score is interpreted across five categories: 0-20% reflects minimal disability, 21-40% indicates moderate disability, 41-60% represents severe disability, 61-80% corresponds to crippled patients, and 81-100% indicates individuals who are bedbound due to their condition.
次要结局
未报告次要终点
研究者
burak menek
Principal Investigator
Istanbul Medipol University Hospital